Victoria C Ziesenitz1,2, Erin Fox3,4, Mark Zocchi5, Samira Samiee-Zafarghandy6, Johannes N van den Anker7,8, Maryann Mazer-Amirshahi9,10. 1. Division of Pediatric Pharmacology and Pharmacometrics, University of Basel Children's Hospital, Basel, Switzerland, ziesenitz.md@gmail.com. 2. Department of Pediatric Cardiology, University Children's Hospital, Heidelberg, Germany, ziesenitz.md@gmail.com. 3. Drug Information Service, University of Utah Health, Salt Lake City, Utah, USA. 4. College of Pharmacy, University of Utah, Salt Lake City, Utah, USA. 5. Center for Healthcare Innovation and Policy Research, George Washington University, Washington, District of Columbia, USA. 6. Division of Neonatology, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada. 7. Division of Pediatric Pharmacology and Pharmacometrics, University of Basel Children's Hospital, Basel, Switzerland. 8. Division of Clinical Pharmacology, Children's National Health System, Washington, District of Columbia, USA. 9. Department of Emergency Medicine, MedStar Washington Hospital Center, Washington, District of Columbia, USA. 10. Georgetown University School of Medicine, Washington, District of Columbia, USA.
Abstract
BACKGROUND: Prescription drug shortages have increased significantly during the past two decades and also impact drugs used in critical care and pediatrics. OBJECTIVES: To analyze drug shortages affecting medications used in neonatal intensive care units (NICUs). METHODS: Drug shortage data for the top 100 NICU drugs were retrieved from the University of Utah Drug Information Service from 2001 to 2016. Data were analyzed focusing on drug class, formulation, reason for shortage, and shortage duration. RESULTS: Seventy-four of the top 100 NICU drugs were impacted by 227 shortages (10.3% of total shortages). Twenty-eight (12.3%) shortages were unresolved as of December 2016. Resolved shortages had a median duration of 8.8 months (interquartile range 3.6-21.3), and generic drugs were involved in 175 (87.9%). An alternative agent was available for 171 (85.8%) drugs but 120 (70.2%) of alternatives were also affected by shortages. Parenteral drugs were involved in 172 (86.4%) shortages, with longer durations than nonparenteral drugs (9.9 vs. 6.4 months, p = 0.022). The most common shortage reason was manufacturing problems (32.2%). CONCLUSIONS: Drug shortages affected many agents used in NICUs, which can have quality and safety implications for patient care, especially in extremely low birth weight infants. Neonatologists must be aware of current shortages and implement mitigation strategies to optimize patient care.
BACKGROUND: Prescription drug shortages have increased significantly during the past two decades and also impact drugs used in critical care and pediatrics. OBJECTIVES: To analyze drug shortages affecting medications used in neonatal intensive care units (NICUs). METHODS: Drug shortage data for the top 100 NICU drugs were retrieved from the University of Utah Drug Information Service from 2001 to 2016. Data were analyzed focusing on drug class, formulation, reason for shortage, and shortage duration. RESULTS: Seventy-four of the top 100 NICU drugs were impacted by 227 shortages (10.3% of total shortages). Twenty-eight (12.3%) shortages were unresolved as of December 2016. Resolved shortages had a median duration of 8.8 months (interquartile range 3.6-21.3), and generic drugs were involved in 175 (87.9%). An alternative agent was available for 171 (85.8%) drugs but 120 (70.2%) of alternatives were also affected by shortages. Parenteral drugs were involved in 172 (86.4%) shortages, with longer durations than nonparenteral drugs (9.9 vs. 6.4 months, p = 0.022). The most common shortage reason was manufacturing problems (32.2%). CONCLUSIONS: Drug shortages affected many agents used in NICUs, which can have quality and safety implications for patient care, especially in extremely low birth weight infants. Neonatologists must be aware of current shortages and implement mitigation strategies to optimize patient care.
Keywords:
Drug shortage; Drug treatment; Extremely low birth weight infants; Neonatal intensive care; Neonatal intensive care unit; Neonate; Preterm and term infant
Authors: Preeya Raja; Mark Duffett; Maryann Mazer-Amirshahi; Ashaka Patel; Andrea Gilpin; Catherine Litalien; Anthony K Chan; John van den Anker; Thierry Lacaze-Masmonteil; Samira Samiee-Zafarghandy Journal: CMAJ Open Date: 2020-08-31
Authors: Katelyn Sushko; Catherine Litalien; Lauren Ferruccio; Andrea Gilpin; Maryann Mazer-Amirshahi; Anthony K Chan; John van den Anker; Thierry Lacaze-Masmonteil; Samira Samiee-Zafarghandy Journal: CMAJ Open Date: 2021-03-17